Approval Letter Other 204311 (Jan 1, 2024)

Summary

The FDA issued two Complete Response Letters for NDA 204311 for Abacavir and Lamivudine Tablets for Oral Suspension, indicating that the application cannot be approved in its current form. The primary reasons for non-approval include unresolved deficiencies from facility inspections at Mylan Laboratories Limited Unit-8 and requirements for revisions to prescribing information, carton/container labeling, and the medication guide. The letters provide detailed instructions for addressing these issues and for resubmitting the application.

Key points

• Satisfactorily resolve all deficiencies identified during the surveillance inspection of Mylan Laboratories Limited Unit-8 manufacturing facility (FEI # 30002785310).
• Ensure proposed Prescribing Information (PI) conforms to content and format regulations at 21 CFR 201.56(a), (d), and 201.57, utilizing FDA's labeling review resources and the Selected Requirements for Prescribing Information (SRPI) checklist.
• Submit updated content of labeling [21 CFR 314.50(l)(1)(i)] in Structured Product Labeling (SPL) format.
• Submit draft carton and container labeling based on FDA's proposed revisions.
• Submit draft Medication Guide based on FDA's proposed revisions.
• Provide a highlighted or marked-up copy and a clean Microsoft Word version of revised labeling, with annotations supporting proposed changes.
• Update Form FDA 356h (Field 20), cover letter, and annotated labeling to omit identification of a specific listed drug (b)(4) as a basis for approval.
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year from the date of the letter.

Cited reasons

• Unsatisfactory resolution of observations from facility inspection
• Proposed Prescribing Information (PI) does not conform to content and format regulations
• Proposed Carton and Container Labeling requires revision
• Proposed Medication Guide requires revision
• The application cannot be approved in its present form due to unresolved manufacturing facility inspection observations and non-compliance of proposed labeling (Prescribing Information, Carton and Container Labeling, Medication Guide) with regulatory content and format requirements.

Recommended actions

• Satisfactorily resolve all deficiencies identified during the surveillance inspection of Mylan Laboratories Limited Unit-8 manufacturing facility (FEI # 30002785310).
• Ensure proposed Prescribing Information (PI) conforms to content and format regulations at 21 CFR 201.56(a), (d), and 201.57, utilizing FDA's labeling review resources and the Selected Requirements for Prescribing Information (SRPI) checklist.
• Submit updated content of labeling [21 CFR 314.50(l)(1)(i)] in Structured Product Labeling (SPL) format.
• Submit draft carton and container labeling based on FDA's proposed revisions.
• Submit draft Medication Guide based on FDA's proposed revisions.
• Provide a highlighted or marked-up copy and a clean Microsoft Word version of revised labeling, with annotations supporting proposed changes.
• Update Form FDA 356h (Field 20), cover letter, and annotated labeling to omit identification of a specific listed drug (b)(4) as a basis for approval.
• Resubmit the application or take other actions available under 21 CFR 314.110 within one year from the date of the letter.

Deficiency summary

The application cannot be approved in its present form due to unresolved manufacturing facility inspection observations and non-compliance of proposed labeling (Prescribing Information, Carton and Container Labeling, Medication Guide) with regulatory content and format requirements.

Findings

Regulatory context

Submission stage

final decision

Regulatory pathway

505(b)(2) of the Federal Food, Drug, and Cosmetic Act

Impact

Impact score

0.95

Estimated delay

365 days

Estimated rework cost

$0

Subsequent action

resubmission

Strategic insights

The primary themes for non-approval are critical manufacturing facility deficiencies and multiple instances of non-compliant labeling across the Prescribing Information, carton/container, and Medication Guide.

Regulatory change impact: Pending sponsor mitigation plan

Approval likelihood after response: 5%